Akorn ophthalmic gel given approvable letter
Akorn Inc. has received an FDA approvable letter for an ocular topical anesthetic 3.5% (Akten Ophthalmic Gel).
Buffalo Grove, IL-Akorn Inc. has received an FDA approvable letter for an ocular topical anesthetic 3.5% (Akten Ophthalmic Gel).
The letter identified several minor deficiencies that have been addressed in previous submissions, according to the company, and the deficiencies need to be rectified before final approval is granted.
No additional clinical data were required for the remaining response submitted to the FDA.